A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)

Purpose

The main purpose of this study is to evaluate the safety and efficacy of donanemab in participants with preclinical Alzheimer's Disease (AD). Approximately 800 additional participants will be enrolled in a 12-month addendum to assess safety of a different titration regimen.

Condition

  • Alzheimer Disease

Eligibility

Eligible Ages
Between 65 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • A Telephone Interview for Cognitive Status - modified (TICS-M) score reflective of intact cognitive functioning. - Has a phosphorylated tau (P-tau) result consistent with the presence of amyloid and early-tau pathology. - Has a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities. - Have adequate literacy, vision, and hearing for neuropsychological testing at screening. - Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies - Female participants include those who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as Mullerian agenesis; or post menopausal (women 55 or older not on hormone therapy and had at least 12 months of spontaneous amenorrhea; or with a diagnosis of menopause prior to starting hormone replacement therapy.

Exclusion Criteria

  • Mild cognitive impairment or dementia, or significant other neurodegenerative disease that can affect cognition. - Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease that could interfere with the analysis of the study or a life expectancy of approximately ≤5 years. - History of cancer with high risk of recurrence and preventing completion of the trial. - History of clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions (including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and/or exfoliative dermatitis). - Have any clinically important abnormality at screening on magnetic resonance imaging (MRI) or clinical laboratory test results that could be detrimental to the participant or study integrity. - Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker. - Have a centrally read MRI demonstrating presence of amyloid-related imaging abnormalities (ARIA-E), >4 cerebral microhemorrhages, more than 1 area of superficial siderosis, any macrohemorrhage or severe white matter disease at screening. - Have had prior treatment with a passive anti-amyloid immunotherapy <5 half-lives prior to randomization. - Have received active immunization against amyloid beta (Aβ) in any other study. - Have received active immunization against Aβ in any other study. - Current or previous use of prescription medications used as treatment for mild cognitive impairment (MCI) or AD. Addendum 7 Exclusion Criteria for Clinicaltrials.gov: - Same as the main study except contraindications for florbetapir F 18 PET are exclusionary.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Donanemab 		Donanemab administered intravenously (IV)
  • Drug: Donanemab
    Administered intravenously
    Other names:
    • LY3002813
Placebo Comparator
Placebo 		Placebo is administered intravenously
  • Drug: Placebo
    Administered intravenously

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77054
Contact:
713-486-0536

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
clinical_inquiry_hub@lilly.com